Director, Biologics Drug Product Development

Biogen

. Lead efforts in designing and developing parenteral dosage formulations from pre-clinical stages to commercial launch .

Posted 11/3/2026full-timeCambridge • Massachusetts • United StatesLead💰 $188,000 - $258,500 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in biopharma drug product development, particularly in liquid and lyophilized formulation development, regulatory compliance, and innovative process technologies. Proven leadership in managing teams and driving cross-functional collaboration to enhance product lifecycle management.

Highest-signal resume keywords

Biopharma Drug Product DevelopmentLiquid And Lyophilized Formulation DevelopmentRegulatory CMC ActivitiesAseptic Drug Product ProcessesTeam Leadership And Cross-Functional Collaboration

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Formulation DevelopmentFill-Finish ProcessesPredictive ModelsProcess StabilityBio-PerformanceScale-Up ProcessesAnalytical DevelopmentCombination Drug-Device ProductsCommercial ManufacturingRegulatory Submissions

Soft Skills

LeadershipCoachingProblem-SolvingCollaborationInfluencing

Industry Keywords

Biologics DevelopmentCDMO PartnershipsGlobal Regulatory RequirementsSubcutaneous ProductsTalent Development

About the role

Key responsibilities & impact

Lead efforts in designing and developing parenteral dosage formulations from pre-clinical stages to commercial launch
Partner with GMTO-led tech transfer teams to influence and progress fill-finish development at internal and external sites
Provide leadership to scientists, managing workload, capacity, and productivity while fostering formulation and process technology innovation
Oversee staff performance, coach career development, and participate in talent reviews and promotions
Drive innovation in technologies for challenging subcutaneous and combination drug-device products
Interact with and influence drug substance, analytical development, and regulatory CMC activities at the Biologics Development level
Develop formulations, fill-finish processes, and primary packaging for new molecules through clinical phases toward scalable and cost-effective commercial manufacturing
Lead the design of new drug products throughout their lifecycle stages
Apply predictive models for molecule developability, process stability, and bio-performance
Oversee direct and matrix reports in internal labs and CDMOs
Manage critical regulatory submissions
Participate in the department leadership team to drive innovation and talent development

Requirements

What you’ll need

Bachelor’s degree
Minimum of 12 years of experience in biopharma drug product and combination drug product development
Expertise in liquid and lyophilized formulation development and commercialization
Proven experience in developing subcutaneous products integrated with delivery solutions
Extensive knowledge of global regulatory requirements for injectable product development
Experience in scale-up of aseptic drug product processes
Proven track record of working with external CDMO partners
Experience in developing process development and stability models for formulation performance
Strong analytical and problem-solving skills
Demonstrated leadership experience through managing a team and cross-functional collaboration

Benefits

Comp & perks

Short-term and long-term incentives, including cash bonus and equity incentive opportunities
Medical, Dental, Vision, & Life insurances
Fitness & Wellness programs including a fitness reimbursement
Short- and Long-Term Disability insurance
A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
Up to 12 company paid holidays + 3 paid days off for Personal Significance
80 hours of sick time per calendar year
Paid Maternity and Parental Leave benefit
401(k) program participation with company matched contributions
Employee stock purchase plan
Tuition reimbursement of up to $10,000 per calendar year
Employee Resource Groups participation